Menu
Recruiting NCT07619287

An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies

Phase I Interventional Myeloid Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BG-75202, Hypomethylation Agent (HMA).
Who it may be relevant to
Registry conditions: Myeloid Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, China, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BG-75202, Alone and in Combination With Other Agents, in Patients With Myeloid Malignancies

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of BG-75202 (KAT6A/B inhibitor) alone and in combination with other agents in patients with myeloid malignancies.

Interventions

  • Drug BG-75202
    Administered orally
  • Drug Hypomethylation Agent (HMA)
    Administered Intravenous (IV) or Subcutaneous (SC)

Primary outcome measures

  • Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months]
  • Phase 1a: Recommended Dose for Expansion (RDFE) of BG-75202 [Time frame: Estimated approximately 18 months]
  • Phase 1b: Dose Optimization: Complete Remission (CR) Rate [Time frame: Up to approximately 12 months]
  • Phase 1b: Dose Optimization: Complete Remission (CR) plus CR With Partial Hematologic Recovery (CRh) Rate [Time frame: Up to approximately 12 months]
Secondary outcome measures (12)
  • Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs) [Time frame: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 18 months]
  • Phase 1b: Time to Response (TTR) [Time frame: Up to approximately 12 months]
  • Phase 1b: CR + Complete Remission with Incomplete Hematologic Recovery (CRi) Rate [Time frame: Up to approximately 12 months]
  • Phase 1a: Dose Escalation: CR + CRh Rate [Time frame: Up to approximately 12 months]
  • Phase 1a and Phase 1b: Overall response rate (ORR) [Time frame: Up to approximately 12 months]
  • Phase 1b: Event Free Survival (EFS) [Time frame: Up to approximately 18 months]
  • Phase 1b: Overall Survival (OS) [Time frame: Up to approximately 18 months]
  • Phase 1b: Transfusion Independence [Time frame: Up to approximately 12 months]
  • Phase 1a and Phase 1b: Observed Plasma Maximum Concentration (Cmax) of BG-75202 [Time frame: Up to approximately 5 months]
  • Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202 [Time frame: Up to approximately 5 months]
  • Phase 1a and Phase 1b: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202 [Time frame: Up to approximately 5 months]
  • Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202 [Time frame: Up to approximately 5 months]

Eligibility criteria

Inclusion criteria

  • Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the Informed consent form (ICF).
  • Patients must have a confirmed diagnosis of myeloid malignancies based on 2016 World Health Organization criteria, and meet the following categories:
  • Relapsed/refractory; myeloid malignancies after ≥1 prior systemic therapy, per ELN; 2022 criteria; patients with actionable genetic alteration must have previously received targeted therapies unless contraindicated, unavailable/inaccessible, or declined by patient.
  • Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion criteria

  • Prior exposure to KAT6A/B inhibitors/degraders.
  • A diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia.
  • Known central nervous system involvement by leukemia
  • Use of antileukemic therapies without sufficient washout period

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • St George Hospital — Kogarah
  • Icon Cancer Centre Kurralta Park — Kurralta Park
  • Linear Clinical Research — Nedlands
China · 3 centers
  • The Second Hospital of Hebei Medical University — Shijiazhuang
  • The First Affiliated Hospital of Nanchang University Branch Donghu — Nanchang
  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestu — Tianjin
New Zealand · 1 center
  • Auckland City Hospital — Auckland

Identifiers

NCT: NCT07619287 · BG-75202-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗